Following USFDA Guidelines in Regards to USP 232 and USP 233

It hasn't been any surprise that the time is finally upon us for regulation changes in the determination of metal toxicity within pharmaceuticals. Public outcry and concerns risen by the pharmaceutical industry resulted in collaborations between the United States Pharmacopeia (USP) Convention, the United States Food and Drug Administration (USFDA), and industry experts in an effort to update a century old USP chapter for detecting trace heavy metals. USP chapter 232 and USP chapter 233 specifically address modern issues regulators were unaware of when the original USP chapter 231 was first drafted. While the actual regulations are only now going into effect, the industry had been notified of the changes a few years earlier. All manufacturers, distributors and other entities marketing drugs within the United States are already expected to be compliant.

The role of the USFDA versus the USP

The primary role of the USFDA is protecting the public's health through regulatory guidelines, such as USP 232 and USP 233. The USFDA also supervises the industry through inspections and investigations, and they enforce laws governing food safety, prescription and over-the counter drugs, and various other venues. Any new drugs are required to go through extensive testing before being introduced to the marketplace. The USFDA also has extensive powers for enforcing post market recalls on dangerous or ineffective drugs.

Unlike the USFDA, the USP does not enforce any of the guidelines. USP guidelines are widely accepted around the world as the standard for the entire pharmaceutical industry, or use some form that is closely related. Every year the USP publishes the United States Pharmacopeia with the National Formulary as a combined volume known as the USP-NF which provides the current written standards the USFDA enforces. USP chapter 232 and USP chapter 233 cover limits for elemental impurities and procedures for elemental impurities respectively.

USP chapter 232

Under the old USP 231 guidelines, the process of testing was antiquated and lacked reliable results. Although some elemental impurities didn't present the same problems as today, such as the various elements used in stainless steel manufacturing equipment. Some additional drawbacks included:


· Subjective analysis

· Loss of target analytes

· Time-consuming

· Broad based testing

· False negatives common

· Lack of modern limitations


USP chapter 232 provides permitted daily exposure limits for known elemental toxicities. It also provides adjusted dosages according to the prescribed method of dispersion.

USP chapter 233

USP chapter 233 deals with the procedures that are acceptable without specifying which procedure has to be utilized. Advanced equipment that use ultrasound, or even infrared, are designed to take measurements without corrupting the samples being tested. The new methods are expected to add accuracy, sensitivity, speed, and efficiency while still maintaining recoveries.

Modern procedures in a modern world

As the pharmaceutical industry continues to move forward as a multi-billion dollar industry, consumers, regulatory agencies, manufacturers and distributors have welcomed the new changes brought forth by USP chapter 232 and USP chapter 233. Every year, the USP adjusts their annual USP-NF, and every year the USFDA takes measures to regulate, supervise, and enforce these and other codes and laws designed to protect the health of the public. With the information and technology available in the modern world today, there are no excuses for ignorance. Staying current with applicable regulations is the responsibility of every pharmaceutical company, and when they fail to do so, it is the duty of the consumer to report them to the USFDA. It is through these combined efforts the pharmaceutical industry is able to provide their much needed medicines to the public while making the necessary adjustments to do it safely and responsibly.

Learn more about the new USP chapters.


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